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FDA grants Moderna’s vaccine full approval


The Food and Drug Administration granted full approval on Monday, Jan. 31, 2022, to Moderna’s coronavirus vaccine, the second-most widely used in the United States and the second to receive full regulatory approval.

By Noah Weiland


The Food and Drug Administration granted full approval earlier this week to Moderna’s coronavirus vaccine, the second-most widely used in the United States and the second to receive full regulatory approval.


The vaccine, which can be administered to adults and has been shown to be highly effective at preventing virus infections and severe cases of COVID-19, has been in use for more than a year under an emergency-use authorization. That rigorous standard lets federal regulators allow use of the shot in a public health emergency before they complete a longer and more detailed review. The vaccine received emergency-use authorization in December 2020.


The full approval of Moderna’s vaccine, which was widely expected, came roughly five months after the company said it had finalized its application for regulators, and after Pfizer and its partner BioNTech, the makers of a similar vaccine, won federal approval in August for use in people 16 and older. That approval set off a cascade of vaccination mandates from institutions that had eagerly awaited the more exhaustive review.


The Pfizer-BioNTech vaccine is cleared for use in people 5 and older and could be authorized for even younger children in the next few months.


More than 204 million doses of the Moderna vaccine have been administered in the United States so far, and nearly 75 million people have been fully vaccinated with it, according to the Centers for Disease Control and Prevention.


“While hundreds of millions of doses of Moderna COVID-19 vaccine have been administered to individuals under emergency use authorization, we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated,” Dr. Janet Woodcock, the acting FDA commissioner, said in a statement Monday.


The CDC panel of vaccine experts is set to meet Friday to review and vote on whether to endorse the approval, as it did with the Pfizer-BioNTech decision in August.


More than 38 million extra shots of the vaccine have also been administered, according to the CDC. Fully vaccinated adults became eligible for Moderna booster shots in the fall. The CDC now considers three doses of the vaccine, with a third dose given five months after the second, to be an “up to date” regimen for most adults. Some people with weakened immune systems recently became eligible for fourth doses.


The new approval also allows Moderna to market its vaccine under the name Spikevax and gives more latitude to physicians to prescribe use of the shot. Controls on how the vaccine is administered were tighter under emergency use authorization.


Dr. Peter Marks, who oversees the agency’s vaccines office, said in a statement that the review involved an independent verification of Moderna’s analysis of its vaccine’s effectiveness; a separate FDA analysis of the data; and a “detailed assessment” of the manufacturing procedures for the vaccine.


Like the Pfizer-BioNTech vaccine, the Moderna shot has been tied to serious but rare heart-related side effects — myocarditis, or inflammation of the heart muscle, and pericarditis, or inflammation of the lining around the heart. Those conditions can also arise from COVID-19 and are typically mild. The side effects have been shown to be especially prevalent in young men.


Concerns over those side effects led federal regulators to continue reviewing Moderna’s application for use of the vaccine in adolescents. Moderna is also studying use of its vaccine in children.


The FDA said Monday that it had conducted a “rigorous evaluation” of the side effects and determined that there was increased risk within a week after a second dose, particularly in men aged 18 to 24. Available short-term follow-up data suggested that symptoms had resolved in most people, the agency said. Regulators conducted a benefit-risk analysis that showed the benefits of the vaccine still outweighed the risks for all adults.


Regulators significantly sped up the amount of time they typically take to fully approve a vaccine, shaving months off a process that experts have said is enormously complex and time-consuming, requiring large teams of FDA reviewers.


Before it approved the Pfizer-BioNTech vaccine, the FDA came under intense pressure from some public health experts, who accused the agency of an overly plodding review that compromised momentum in the national vaccination campaign. Public polling at the time showed that some Americans would be likelier to get the shot if it were fully approved.

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